Rapid Diagnosis of XDR and Pre-XDR TB: A Systematic Review of Available Tools

Laura Saderi; Mariangela Puci; Biagio Di Lorenzo; Rosella Centis; Lia D'Ambrosio; Onno W Akkerman; Jan-Willem C Alffenaar; José A Caminero; Jeremiah Muhwa Chakaya; Justin T Denholm; Xhevat Kurhasani; Catherine W M Ong; Adrian Rendon; Denise Rossato Silva; Simon Tiberi; Dominik Zenner; Andrea M Cabibbe; Giovanni Battista Migliori; Giovanni Sotgiu

doi:10.1016/j.arbres.2022.07.012

Rapid Diagnosis of XDR and Pre-XDR TB: A Systematic Review of Available Tools

Arch Bronconeumol. 2022 Dec;58(12):809-820. doi: 10.1016/j.arbres.2022.07.012. Epub 2022 Jul 28.

[Article in English, Spanish]

Authors

Laura Saderi¹, Mariangela Puci¹, Biagio Di Lorenzo¹, Rosella Centis², Lia D'Ambrosio³, Onno W Akkerman⁴, Jan-Willem C Alffenaar⁵, José A Caminero⁶, Jeremiah Muhwa Chakaya⁷, Justin T Denholm⁸, Xhevat Kurhasani⁹, Catherine W M Ong¹⁰, Adrian Rendon¹¹, Denise Rossato Silva¹², Simon Tiberi¹³, Dominik Zenner¹⁴, Andrea M Cabibbe¹⁵, Giovanni Battista Migliori¹⁶, Giovanni Sotgiu¹

Affiliations

¹ Department of Medicine, Surgery and Pharmacy, University of Sassari, Sassari, Italy.
² Respiratory Diseases Clinical Epidemiology Unit, Istituti Clinici Scientifici Maugeri, IRCCS, Tradate, Italy.
³ Public Health Consulting Group, Lugano, Switzerland.
⁴ University of Groningen, University Medical Center Groningen, Department of Pulmonary Diseases and Tuberculosis, Groningen, The Netherlands; University of Groningen, University Medical Center Groningen, TB Center Beatrixoord, Haren, The Netherlands.
⁵ Sydney Institute for Infectious Diseases, University of Sydney, Sydney, NSW, Australia; School of Pharmacy, Faculty of Medicine and Health, University of Sydney, Sydney, NSW, Australia; Westmead Hospital, Sydney, NSW, Australia.
⁶ Pneumology Department, Universitary Hospital of Gran Canaria "Dr. Negrin", Las Palmas de Gran Canaria, Spain; ALOSA TB Academy, Las Palmas de Gran Canaria, Spain.
⁷ Department of Medicine, Therapeutics and Dermatology, Kenyatta University, Nairobi, Kenya; Department of Clinical Sciences, Liverpool School of Tropical Medicine, Liverpool, United Kingdom.
⁸ Victorian Tuberculosis Program, Melbourne Health and Department of Infectious Diseases, University of Melbourne at the Peter Doherty Institute for Infection and Immunity, Parkville, Victoria, Australia.
⁹ UBT Higher Education Institution, Prishtina, Kosovo.
¹⁰ Infectious Diseases Translational Research Programme, Department of Medicine, Yong Loo Lin School of Medicine, National University of Singapore, Singapore; Division of Infectious Diseases, Department of Medicine, National University Hospital of Singapore, Singapore; Institute for Health Innovation and Technology (iHealthtech), National University of Singapore, Singapore.
¹¹ Centro de Investigación, Prevención y Tratamiento de Infecciones Respiratorias CIPTIR, Hospital Universitario "Dr. Jose Eleuterio Gonzalez", Universidad Autónoma de Nuevo León, Monterrey, Mexico.
¹² Faculdade de Medicina, Universidade Federal do Rio Grande do Sul (UFRGS), Porto Alegre, Brazil.
¹³ Blizard Institute, Barts and the London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.
¹⁴ Global Public Health Unit, Wolfson Institute of Population Health, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, London, United Kingdom.
¹⁵ Emerging Bacterial Pathogens Unit, IRCCS San Raffaele Scientific Institute, Milan, Italy.
¹⁶ Respiratory Diseases Clinical Epidemiology Unit, Istituti Clinici Scientifici Maugeri, IRCCS, Tradate, Italy. Electronic address: giovannibattista.migliori@icsmaugeri.it.

PMID: 35945071
DOI: 10.1016/j.arbres.2022.07.012

Abstract

Introduction: No previous systematic reviews have comprehensively investigated the features of Xpert MTB/XDR and other rapid tests to diagnose pre-XDR/XDR-TB. The aim of this systematic review is to assess existing rapid diagnostics for pre-XDR/XDR-TB from a point-of-care perspective and describe their technical characteristics (i.e., sensitivity, specificity, positive and negative predictive values).

Methods: Embase, PubMed, Scopus, and Web of Science were searched to detect the articles focused on the accuracy of commercially available rapid molecular diagnostic tests for XDR-TB according to PRISMA guidelines. The analysis compared the diagnostic techniques and approaches in terms of sensitivity, specificity, laboratory complexity, time to confirmed diagnosis.

Results: Of 1298 records identified, after valuating article titles and abstracts, 97 (7.5%) records underwent full-text evaluation and 38 records met the inclusion criteria. Two rapid World Health Organization (WHO)-endorsed tests are available: Xpert MTB/XDR and GenoType MTBDRsl (VER1.0 and VER 2.0). Both tests had similar performance, slightly favouring Xpert, although only 2 studies were available (sensitivity 91.4-94; specificity 98.5-99; accuracy 97.2-97.7; PPV 88.9-99.1; NPV 95.8-98.9).

Conclusions: Xpert MTB/XDR could be suggested at near-point-of-care settings to be used primarily as a follow-on test for laboratory-confirmed TB, complementing existing rapid tests detecting at least rifampicin-resistance. Both Xpert MTB/XDR and GenoType MTBDRsl are presently diagnosing what WHO defined, in 2021, as pre-XDR-TB.

Keywords: Drug susceptibility test; GenoType MTBDRsl; Line probe assay; MDR-TB; Pre-XDR; Sensitivity; Specificity; Tuberculosis; XDR-TB; Xpert MTB/XDR.

Publication types

Systematic Review

MeSH terms

Extensively Drug-Resistant Tuberculosis* / diagnosis
Genotype
Humans
Mycobacterium tuberculosis* / genetics
Predictive Value of Tests
Rifampin
Sensitivity and Specificity
Tuberculosis, Multidrug-Resistant* / diagnosis

Substances

Rifampin